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Compliance Program Guidance Manual

(public access version)

Content updated: 12/17/2003 (pmb) test
Page edited: 09/28/2003 (web team)

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.  These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available.

Numerical listing of all FDA Compliance Programs with hyperlinks to those available electronically on FDA websites, organized by these program areas:

Reference: FDA Freedom of Information Act Handbook for Requesting Information and Records from FDA

Foods and Cosmetics

Program # Compliance Program Title On-line Availability
7303.003 Import Acidified and Low Acid Canned Foods Program Link to CFSAN list
7303.037 Domestic and Imported Cheese and Cheese Products Link to CFSAN list
7303.039 National Drug Residue Milk Monitoring Program Link to CFSAN list
7303.803 Domestic Food Safety Link to CFSAN list
7303.803A Domestic Acidified and Low-Acid Canned Foods Link to CFSAN list
7303.819 Imported Foods - General Program not on-line
7303.842 Domestic Fish and Fishery Products Inspection Program Link to CFSAN list
7303.844 Import Seafood Products Link to CFSAN list
7303.847 Juice HACCP Inspection Program not on-line
7304.004 Pesticides and Industrial Chemicals in Domestic Foods Link to CFSAN list
7304.016 Pesticides and Industrial Chemicals in Imported Foods Link to CFSAN list
7304.018 Chemotherapeutics in Seafood Compliance not on-line
7304.019 Toxic Elements in Food and Foodware Import and Domestic Link to CFSAN list
7304.839 Total Diet Studies Link to CFSAN list
7307.001 Mycotoxins in Domestic Foods Link to CFSAN list
7307.002 Mycotoxins in Imported Foods Link to CFSAN list
7309.006 Imported Foods - Food and Color Additives Link to CFSAN list
7318.002 Retail Food Protection - State Link to CFSAN list
7318.003 Milk Safety Program Link to CFSAN list
7318.004 Molluscan Shellfish Evaluation not on-line
7318.029 Interstate Travel Program Link to CFSAN list
7321.002 Medical Foods - Import and Domestic Link to CFSAN list
7321.005 Domestic NLEA, Nutrient Sample Analysis General Food Labeling Program Link to CFSAN list
7321.006 Infant Formula Program - Import and Domestic Link to CFSAN list
7321.007 NLEA Enforcement - Imports not on-line
7321.008 Food Composition, Standards, Labeling And Economics Dietary Supplements - Import and Domestic Link to CFSAN list
7329.001 Domestic Cosmetics Program Link to CFSAN list
7329.002 Imported Cosmetics  Program Link to CFSAN list

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Biologics

Program # Compliance Program Title On-line Availability
7341.001 Inspections of Licensed Therapeutic Drug Products not on-line
7341.002 Inspection of Tissue Establishments Link to CBER list
7342.001 Inspection of Licensed and Unlicensed Blood Banks Link to CBER list
7342.002 Inspection of Source Plasma Establishments Link to CBER list
7342.006 Inspections of Plasma Derivatives of Human Origin Link to CBER list
or Link to PDF version of 7342.006 (3282 kb)
7342.007 Examination of Blood and Blood Components Offered for Import (ongoing) not on-line
7342.008 Inspections of Licensed Viral Marker Test Kits Link to CBER list
or Link to PDF version of 7432.008 (3129 kb)
7345.001 Inspections of Licensed Allergenic Products Link to CBER list
or Link to PDF version of 7345.001 (2729 kb)
7345.002 Inspections of Licensed Vaccines Link to CBER list

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BIMO

Program # Compliance Program Title On-line Availability
7348.001 In Vivo Bioequivalence Link to HTML version of 7348.001 Link to PDF version of 7348.001 (78 kb)
7348.808 Good Laboratory Practice (Nonclinical Laboratories) Link to HTML version of 7348.808 Link to PDF version of 7348.808 (117 kb)
7348.808A Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections Link to HTML version of 7348.808A Link to PDF version of 7348.808A (38 kb)
7348.809 Institutional Review Board Link to PDF version of 7348.809 (293 kb)
7348.809A Radioactive Drug Research Committee not on-line
7348.810 Sponsors, Contract Research Organization and Monitors Link to HTML version of 7348.810 Link to PDF version of 7348.810 (80 kb)
7348.811 Clinical Investigators Link to HTML version of 7348.811 Link to PDF version of 7348.811 (2437 kb)

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Drugs

Program # Compliance Program Title On-line Availability
7346.832 Pre-Approval Inspections/Investigations
Link to PDF version of 7346.832(156kb)
7346.843 Post-Approval Audit Inspections Link to PDF version of 7346.832(159kb)
7352.002 New Drugs (Rx) Not Covered by Approved NDA's not on-line
7352.004 In Vitro Methods Development and Validation for Generic Drugs not on-line
7353.001 Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations Link to HTML version of 7353.001
7356.002 Drug Manufacturing Inspections Link to HTML version of 7356.002   Link to PDF version of 7356.002 (80 kb)
7356.002A Sterile Drug Process Inspections Link to PDF version of 7356.002A (79 kb)
7356.002B Drug Repackers and Relabelers Link to PDF version of 7356.002B (189 kb)
7356.002C Radioactive Drugs Link to PDF version of 7356.002C (187 kb)
7356.002E Compressed Medical Gases Link to PDF version of 7356.002E (249 kb)
7356.002F Active Pharmaceutical Ingredients Link to PDF version of 7356.002F (252 kb)
7356.002M Inspections of Licensed Biological Therapeutic Drug Products Link to PDF version of 7356.002M (89 kb) Link to HTML version of 7353.002M
7356.008 Drug Product Surveillance not on-line
7356.014 Drug Listing not on-line
7356.014A Drug Listing - Labeling Review not on-line
7356.020 Compendial Monographs Evaluation and Development (CMED) not on-line
7356.020A Compendial Methods Assessment not on-line
7356.021 Drug Quality Reporting System NDA Field Alert Reporting not on-line
7356.022 Enforcement of the Prescription Drug Marketing Act (PDMA) not on-line
7356.818 Government-Wide Quality Assurance not on-line
7361.003 OTC Drug Monograph Implementation not on-line

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Veterinary Medicine

Program # Compliance Program Title On-line Availability
7368.001 Pre-Approval Inspection New Animal Drug Applications (NADA) Abbreviated New Animal Drug Applications (ANADA) not on-line
7371.001 Drug Process and New Animal Drug Inspections not on-line
7371.002 Illegal Sales of Veterinary Prescription Drugs not on-line
7371.003 Feed Contaminants Program not on-line
7371.004 Feed Manufacturing Compliance Program not on-line
7371.005 Type A Medicated Articles not on-line
7371.006 Illegal Drug Residues in Meat & Poultry Program not on-line
7371.007 Imported Bulk New Animal Drugs not on-line
7371.008 National Drug Residue Milk Monitoring not on-line
7371.009 BSE/Ruminant Feed Ban Inspections Link to PDF version of 7371.009 (1.02mb) Link to WORD version of 7371.009 (614 kb)

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Devices

Program # Compliance Program Title On-line Availability
7382.008 Monitoring Devices of Foreign Origin Import not on-line
7382.013 Conformance Assessment of Devices to Product Specifications in Pre-Market Notifications (510(k)s) not on-line
7382.845 Inspections of Medical Device Manufacturers (Full document) Link to PDF version of 7382.845 (327 kb)
 Cover Page

Link to HTML version of the Cover Page of 7382.845 Link to WORD version of the Cover Page of 7382.845 (54 kb)
 Part I Link to HTML version of the Part I of 7382.845 Link to WORD version of Part I of 7382.845 (37 kb)
 Part II Link to HTML version of the Part II of 7382.845 Link to WORD version of Part II of 7382.845 (49 kb)
 Part III Link to HTML version of Part III of 7382.845 Link to WORD version of Part III of 7382.845 (83 kb)
 Part IV Link to HTML version of Part IV of 7382.845 Link to WORD version of Part IV of 7382.845 (35 kb)
 Part V Link to HTML version of Part V of 7382.845 Link to WORD version of Part V of 7382.845 (35 kb)
 Part VI Link to HTML version of Part VI of 7382.845 Link to WORD version of Part VI of 7382.845 (84 kb)
 Cross Reference Index Link to HTML version of the Cross Reference Index of 7382.845 Link to WORD version of the Cross Reference Index 7382.845 (62 kb)
 Office of Compliance Organizational Structure (HTML version readable, but formatting lost) Link to HTML version of the Office of Compliance Organizational Structure Link to WORD version of the Office of Compliance Organizational Structure (27 kb)
 Attachment A Link to HTML version of Attachment A of 7382.845 Link to WORD version of Attachment A of 7382.845 (62 kb)
 Attachment B Link to HTML version of Attachment B of 7382.845 Link to WORD version of Attachment B of 7382.845 (75 kb)
 Attachment B-1 Link to HTML version of Attachment B-1 of 7382.845 Link to WORD version of Attachment B-1 of 7382.845 (29 kb)
 Attachment C Link to HTML version of Attachment C of 7382.845 Link to WORD version of Attachment C of 7382.845 (45 kb)
 Attachment D Link to PDF version of Attachment D of 7382.845 (9 kb)
 Attachment E Link to HTML version of Attachment E of 7382.845 Link to WORD version of Attachment E of 7382.845 (59 kb)
 Attachment F Link to HTML version of Attachment F of 7382.845 Link to WORD version of Attachment F of 7382.845 (41 kb)
 Attachment G Link to HTML version of Attachment G of 7382.845 Link to WORD version of Attachment G of 7382.845 (32 kb)
7383.001 Medical Device Premarket Approval and Postmarket Inspections not on-line
7383.003 510(k) Premarket Approval Inspections not on-line
7385.014 Mammography Facility Inspections not on-line
7386.001 Inspection of Manufacturers of Laser Products not on-line
7386.002 Field Implementation of the Sunlamp and Sunlamp Products Performance Standard As Amended Link to HTML version of 7386.002 Link to PDF version of 7386.002(530 kb)
7386.003 Field Compliance Testing of Diagnostic Medical X-Ray Equipment Link to PDF version of 7386.003 (75 kb) Link to WORD version of 7386.003 (143 kb)
 Attachments A-C Link to PDF version of Attachments A-C of 7386.003 (9 kb) Link to WORD version of Attachments A-C of 7386.003 (28 kb)
 Attachment D Link to PDF version of Attachment D of 7386.003 (25 kb) Link to WORD version of Attachment D of 7386.003 (53 kb)
 Attachment E Link to PDF version of Attachments E of 7386.003 (672 kb) Link to WORD version of Attachment E of 7386.003 (126 kb)
 Attachment F Link to PDF version of Attachment F of 7386.003 (30 kb) Link to WORD version of Attachment F of 7386.003 (122 kb)
 Attachment G Link to PDF version of Attachment G of 7386.003 (27 kb) Link to WORD version of Attachment G of 7386.003 (61 kb)
 Attachments H-K Link to PDF version of Attachments H-K of 7386.003 (22 kb) Link to WORD version of Attachments H-K of 7386.003 (46 kb)
 Attachment L Link to PDF version of Attachment L of 7386.003 (7 kb) Link to WORD version of Attachment L of 7386.003 (24 kb)
 Attachment M Link to PDF version of Attachment M of 7386.003 (37 kb) Link to WORD version of Attachment M of 7386.003 (74 kb)
7386.004 Field Compliance Testing of Cabinet X-Ray Equipment Link to HTML version of 7386.004 Link to PDF version of 7386.004 (71 kb)
7386.006 Compliance Testing of Electronic Products at WEAC not on-line
7386.007 Imported Electronic Product not on-line
7386.007A Imported Non-certified Radiation-Emitting Electronic Products (Special Exemption for Television Receivers, Microwave Ovens, and Certain Class I Laser Products not on-line
7386.008 Medical Device and Radiological Health Use Control and Policy Implementation not on-line
7386.009 Emergency Planning and Response Activities
Part VI		 not on-line

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